When interventional catheter devices are inserted into the vascular system, the physician usually starts with a needle stick, followed by dilating the artery in order to insert an introducer sheath device that is left in place for the duration of the procedure. This introducer sheath acts as the main conduit for entry of subsequent therapeutic or diagnostic devices. In most instances, these introducer sheaths contain a hemostatic component that restricts back-flow of blood from the artery. These hemostasis seals are generally passive and provide sealing around the catheter devices and guide wires that are used during the procedure.
Current devices and prior art for hemostasis seals have limited performance when they are made for large size devices. This is due to the extreme size difference between the large catheter device and the much smaller guide wire used in these procedures. When larger catheter devices are used (such as 14-20 Fr), it can be difficult to seal on both this large diameter and on the guide wires used in these types of procedures, which are generally 0.035″ in diameter. Current seals tend to leak when only the guide wire is in place or when nothing is in place, especially after large diameter devices have passage through the sealing device and have stretched or damaged the seal in the process.
It is the objective of this invention to provide a hemostasis sealing device for large bore interventional devices that provides a leak-proof or leak resistant blood seal on both guide wire passage as well as device passage through the seal.